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 Zambia HIV National Guidelines


HIV Counseling and Testing  

Sexually Transmitted Infections (STIs)  

General Principles of Antiretroviral Therapy for Chronic HIV Infection in Adults and Adolescents  

When to Start ARV Therapy for Chronic HIV Infection in Adults and Adolescents  

Initial Regimen for ARV Therapy  


Baseline evaluation and Monitoring  

Calculations: Ideal Body Weight, Body Mass Index and Creatinine Clearance  

ARV Therapy for Individuals with Tuberculosis Co-Infection  

Adverse Effects and Toxicity  

Immune Reconstitution Inflammatory Syndrome (IRIS)  

Changing or Stopping ART  

Treatment Failure  

Stopping ARV Therapy  

Post Exposure Prophylaxis  

Cotrimoxazole Prophylaxis  

WHO Staging in Adults and Adolescents  

Nutrition Care and Support  

Palliative Care in HIV and AIDS  

 Guide Editors
 Editor In Chief
    Joel E. Gallant, MD, MPH

Pharmacology Editor
    Paul Pham, PharmD, BCPS

Zambia Guideline Team
   Peter Mwaba MMed PhD FRCP
   Alywn Mwinga MMed
   Isaac Zulu MMed MPH
   Velepie Mtonga MMed
   Albert Mwango MBChB
   Jabbin Mulwanda MMed FCS



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Treatment Failure


Clinical Failure

  • Clinical disease progression signalled by new or recurrent WHO Stage 3 or 4 condition when ART has been given sufficient time to induce protective degree of immune restoration (>6 months). Often associated with weight loss and drop in hemoglobin
  • Exclude IRIS. IRIS not indication for changing ART
  • Virologic failure occurs first followed by immunologic and then clinical failure.
Immunologic failure

  • Fall in CD4 count to 50% of peak value on treatment OR decline to pre-therapy baseline or below OR persistent CD4 count below 50 after 12 months on therapy.
  • If CD4 increase <50 at 6 months review patient and consider treatment failure.
  • When ART started with advanced disease, may take longer to see clinical or immunologic improvement; in some cases patients may never achieve substantial CD4 increase
Virologic failure

  • When VL testing available, VL >400 after 6 months on therapy suggests failure
  • Blips (single VL 50-1000) not considered failure; repeat VL as soon as possible
  • In patients who appear to be failing with undetectable VL, consider undiagnosed OIs or other concomitant illnesses.
Factors Leading to Treatment Failure

  • Poor adherence
  • Prior exposure to ART with development of resistance
  • Primary viral resistance (infection with resistant strain)
  • Inadequate drug absorption
  • Suboptimal dosing (e.g., sharing drugs, cutting dose because of side effects)
  • Inadequate or inconsistent drug supply
Clinical Disease Progression as Indicator of Treatment Failure (T-Staging)

Clinical events occurring in first 6 months of therapy often represent IRIS related to pre-existing conditions and are excluded from definition of clinical failure. New or recurrent WHO stage 3 or 4 conditions after 1st 6 months of treatment with good adherence considered functional evidence of disease progression. Referred to as T-staging (T=staging event whilst on treatment). Table below indicates how clinical staging on ART can be used as indicator of failure prompting consideration of need to switch therapy.

  • Asymptomatic (T1) a
  • Recommendation: Do not switch regimen
  • Maintain scheduled follow-up visits, including CD4 monitoring (if available)
  • Continue to offer adherence support
  • Stage 2 event (T2) a
  • Recommendation: Do not switch regimenb
  • Treat and manage staging event
  • Assess and offer adherence support
  • Check if on treatment for at least 6 months
  • Assess continuation or reintroduction of OI prophylaxis
  • Schedule earlier visit for clinical review and consider CD4 (if available)c
  • Stage 3 event (T3) a
  • Recommendation: Consider switching regimenb,d
  • Treat and manage staging event and monitor response
  • Assess and offer adherence support
  • Check if on treatment for at least 6 months
  • Check CD4 cell count (if available)c,d
  • Assess continuation or reintroduction of OI prophylaxis
  • Institute more frequent follow-up
  • Stage 4 event (T4) a
  • Recommendation: Switch regimenb,e
  • Treat and manage staging event and monitor response Check CD4 cell count (if available)c
  • Check if on treatment for at least 6 months
  • Assess continuation or reintroduction of OI prophylaxis
  • Assess and offer adherence support

a. Refers to clinical stages while on ART for at least 6 months (termed T1, T2, T3, T4).

b. Differentiation of OIs from IRIS necessary.

c. Treat and manage staging event before measuring CD4 count.

d. Certain WHO clinical stage 3 conditions (e.g. pulmonary TB, severe bacterial infections) may be indicators of treatment failure and thus require consideration of 2nd-line therapy; response to appropriate therapy should be used to evaluate need for switching therapy.

e. Some WHO clinical stage 4 conditions (lymphatic TB, uncomplicated TB pleural disease, oesophageal candidiasis, recurrent bacterial pneumonia) may not be indicators of treatment failure and thus do not require consideration of 2nd-line therapy.



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Zambia HIV National Guidelines


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